MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC QUICK-SET PARADIGM; INSULIN PUMP INFUSION SET

Model Number UNKNOWN

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Stroke/CVA (1770); Death (1802); Hypoglycemia (1912)

Event Date 01/07/2018

Event Type  Death  

Manufacturer Narrative

The only available information is provided.This information does not allow unomedical, at present, to provide a proper, nonspeculative clinical/medical assessment.If further relevant information becomes available unomedical will submit a follow-up, supplemental mdr report to fda within 30 days after receiving such new relevant information.

Event Description

Unomedical reference (b)(4).This complaint case is a legal case.Presently our information is restricted to a lawyer-authored description of the incident: "on or about (b)(6) 2017, (b)(6) was a healthy, (b)(6) resident of (b)(6).She worked as a loan officer at a local bank.(b)(6) was married to (b)(6), and she had two (2) children: (b)(6).(b)(6) was a diabetic, and she used a medtronic minimed insulin pump to deliver the necessary amount of insulin into her blood stream to properly treat her diabetes.Said minimed insulin pump stored up to one week's worth of insulin.The insulin is delivered from the pump to the patient's body through plastic tubes called "infusion sets." (b)(6) used medtronic minimed quick-set infusion sets to deliver the insulin from the pump to her body.On or about the night of (b)(6) 2017, at her home in (b)(6), (b)(6) changed her insulin set and loaded her insulin pump, which contains enough insulin to last up to one week.(b)(6) then went to bed.The next morning, on (b)(6) 2017, (b)(6) would not wake up.(b)(6) was unable to wake her, and paramedics were called to the (b)(6) home.Sometime after going to bed on (b)(6) 2017, (b)(6) suffered a stroke resulting from severe hypoglycemia.Sometime after loading her insulin pump on the night of (b)(6) 2017, the medtronic minimed insulin pump delivered up to a week's worth of insulin at one time into (b)(6)'s body.The large amount of insulin resulted in severe hypoglycemia and, ultimately, a stroke, from which (b)(6) never recovered.(b)(6) was subsequently taken to (b)(6) medical center, where she survived for over two (2) months before ultimately dying from the injuries at issue in this lawsuit on march 14, 2017.".

• Brand Name: MEDTRONIC QUICK-SET PARADIGM
• Type of Device: INSULIN PUMP INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3, osted; lejre, 4320
• MDR Report Key: 7917691
• MDR Text Key: 122001546
• Report Number: 3003442380-2018-00031
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K106648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 56 YR